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Abbott Nutrition Baby Formula Plant Reopening Overview:
- Who: The U.S. Food and Drug Administration has come to an agreement with Abbott Nutrition which will allow Abbott to reopen its baby formula plant in Sturgis, Michigan.
- Why: The facility was shut down by the FDA in February after two babies died due to contamination potentially linked to baby formula produced by Abbott.
- Where: The facility is in Sturgis, Michigan.
Abbott Nutrition has come to an agreement with the U.S. Food and Drug Administration which will allow the company to reopen its baby formula plant in Michigan.
The plant was closed in February as regulators investigated the source of a salmonella and Cronobacter sakazakii contamination following the deaths of two babies who had consumed Abbott’s Similac PM 60/40 baby formula.
The FDA and Abbott have now reached an agreement on a reopening plan in the midst of an ongoing nationwide shortage of baby formula, with the latter saying it could have its plant in Sturgis, Michigan back up and running within as little as two weeks.
Court approval still needs to be given for a consent decree filed jointly by the FDA and Abbott on May 16.
As part of the agreement, Abbott must, at their own expense, “retain or continue retention” of an outside expert who does not have any personal or financial ties to the company and can help bring it into compliance and avoid future bacterial contamination.
The FDA will require Abbott to notify them in writing of the “identity and qualifications of the Expert within two days after retaining the Expert.”
Abbott Says It Has Been Working On Improving Safety at Plant
Abbott has said that it was already working on improving health and safety regulations at the plant prior to it being shut down by the FDA, according to court documents.
The FDA says it will need to be able to determine that Abbott has made the necessary changes and upgrades to the plant before the facility will ultimately be able to reopen.
Once the facility is given the okay to reopen, Abbott says it will initially begin producing Alimentum, EleCare, and metabolic formulas before restarting production of Similac and others.
Abbott says it will take between six and eight weeks after production is restarted at the plant for the baby formulas to be back on the shelves, according to court documents.
In February, two senators demanded that Abbott turn over documents related to its baby formula recall after it came to light that the company, the FDA, and the CDC knew since September 2021 that the formula had been making babies sick.
Did your baby develop necrotizing enterocolitis after being born prematurely and given formula while in the NICU or after? You could qualify to join a free preemie baby formula lawsuit investigation.
The Case is USA v. Abbott Laboratories, et al., Case No. 1:22-cv-00441, in the U.S. District Court for the Western District of Michigan.
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One thought on Abbott Nutrition Reaches Deal With FDA To Reopen Baby Formula Plant Amid Shortage
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